Metastatic Breast Cancer
Conditions
Keywords
hormone receptor, positive/human epidermal growth factor 2 - negative (HR+/HER2-)
Brief summary
The purpose of this study is to understand the treatment patterns, patients and their clinical outcomes in a real life setting in Israel. This study was done in adult breast cancer patients who have started palbociclib combination treatment as per the national basket of health services in January 2018 until August 2020 for all lines of therapy. This study had included adult patients who were prescribed with palbociclib for their breast cancer which had spread to other parts of the body. Patients are followed for around 3.5 years.
Interventions
DRUGpalbociclib
As provided in real world practice
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* A diagnosis of metastatic breast cancer, based on the National/MHS cancer registry. * Newly diagnosed metastatic breast cancer patients and newly treated with palbociclib within 6 months of diagnosis, in any line of treatment in the metastatic setting. * Available data on palbociclib treatment for at least 6 months. * Continuous healthcare plan enrolment in MHS for at least one year before index date.
Exclusion criteria
* Patients that initiated HER2 inhibitors.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Categorized According to Type of Index Combination Treatment Regimen | Day 1 of index treatment (any day from 01 January 2018 to 30 June 2020 [index period]), data observed and evaluated during 18 months of this retrospective study | Number of participants were classified on the basis of type of combination treatment along with palbociclib as first line therapy. Index treatment was palbociclib combination treatment. Index period was defined as duration in which participant initiated palbociclib combination treatment. |
| Duration of Index Treatment Per Type of Combination Treatment | Day 1 of index treatment till discontinuation of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study | Duration in months between the start and stop of therapy was reported. Index treatment was palbociclib combination treatment. Kaplan-Meier method was used for the assessment of this outcome measure. |
| Number of Participants Categorized According to Number of Cycles of Index Treatment Per Type of Combination Treatment | Day 1 of index treatment till discontinuation of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study | Number of participants categorized according to number of cycles of treatment including less than or equal to (\<=) 6, greater than (\>) 6 to 11, \>11 to 20 and \>20 cycles were reported. Index treatment was palbociclib combination treatment. |
| Number of Participants Categorized According to Initial Palbociclib Dose Per Type of Combination Treatment | Day 1 of index treatment (any day from 01 January 2018 to 30 June 2020 [index period]), data observed and evaluated during 18 months of this retrospective study | Number of participants were categorized according to initial palbociclib dose. Index treatment was palbociclib combination treatment. Index period was defined as duration in which participant initiated palbociclib combination treatment. |
| Number of Participants With Modification (Reduction) in Initial Palbociclib Dose Per Type of Combination Treatment | Day 1 of index treatment till discontinuation of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study | Number of participants who had a reduction in initial palbociclib dose were reported. Index treatment was palbociclib combination treatment. |
| Time on Treatment for Subsequent Treatment After Palbociclib Therapy Per Type of Combination Treatment | Day 1 of subsequent treatment till last dose of subsequent treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study | Subsequent treatment after palbociclib therapy was the regimen received by participants following discontinuation from the palbociclib treatment and included chemotherapy, everolimus, fulvestrant and other. The duration between the start and stop of the post-palbociclib treatment was reported in this outcome measure. Index treatment was palbociclib combination treatment. Kaplan-Meier method was used for the assessment of this outcome measure. |
| Percentage of Participants With Ongoing Index Treatment at Month 6 Per Type of Combination Treatment | Day 1 of index treatment up to Month 6 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study | Percentage of participants with ongoing index treatment at Month 6 were reported. Index treatment was palbociclib combination treatment. |
| Percentage of Participants With Ongoing Index Treatment at Month 12 Per Type of Combination Treatment | Day 1 of index treatment up to Month 12 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study | Percentage of participants with ongoing index treatment at Month 12 were reported. Index treatment was palbociclib combination treatment. |
| Percentage of Participants With Ongoing Index Treatment at Month 24 Per Type of Combination Treatment | Day 1 of index treatment up to Month 24 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study | Percentage of participants with ongoing index treatment at Month 24 were reported. Index treatment was palbociclib combination treatment. |
| Number of Participants Who Died Following Initiation of Index Treatment up to Month 6 Per Type of Combination Treatment | Day 1 of index treatment up to Month 6 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study | Number of participants who died following index treatment up to Month 6 were reported. Index treatment was palbociclib combination treatment. |
| Number of Participants Who Died Following Initiation of Index Treatment up to Month 12 Per Type of Combination Treatment | Day 1 of index treatment up to Month 12 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study | Number of participants who died following index treatment up to Month 12 were reported. Index treatment was palbociclib combination treatment. |
| Number of Participants Who Died Following Initiation of Index Treatment up to Month 24 Per Type of Combination Treatment | Day 1 of index treatment up to Month 24 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study | Number of participants who died following index treatment up to Month 24 were reported. Index treatment is palbociclib combination treatment. |
| Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 6 Per Type of Combination Treatment | Day 1 of index treatment up to Month 6 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study | Subsequent treatment after palbociclib therapy was the regimen received by participants following discontinuation from the palbociclib treatment. Number of participants who advanced and did not advance to a subsequent treatment up to Month 6 were reported. Index treatment is palbociclib combination treatment. |
| Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 12 Per Type of Combination Treatment | Day 1 of index treatment up to Month 12 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study | Subsequent treatment after palbociclib therapy was the regimen received by participants following discontinuation from the palbociclib treatment. Number of participants who advanced and did not advance to a subsequent treatment up to Month 12 were reported. Index treatment is palbociclib combination treatment. |
| Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 24 Per Type of Combination Treatment | Day 1 of index treatment up to Month 24 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study | Subsequent treatment after palbociclib therapy was the regimen received by participants following discontinuation from the palbociclib treatment. Number of participants who advanced and did not advance to a subsequent treatment up to Month 24 were reported. Index treatment is palbociclib combination treatment. |
| Time to Initiation of Chemotherapy After Cessation of Initial Palbociclib Therapy Per Type of Combination Treatment | From cessation of index treatment up to initiation of chemotherapy (during 01 January 2018 to 31 December 2020 [approximately 36 months]); data observed and evaluated during 18 months of this retrospective study | Time to initiation of chemotherapy was the duration from end of index treatment up to start of chemotherapy. Index treatment is palbociclib combination treatment. |
| Time to Initiation of Next Treatment (TTNT) From Initiation of Palbociclib Treatment Per Type of Combination Treatment | Day 1 of index treatment up to initiation of next treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study | TTNT was defined as the interval between the start of the index treatment date and the date of the next-line treatment. Participants who did not advance to the next treatment were censored on the study end date or death, whichever occurred first. Index treatment is palbociclib combination treatment. Kaplan-Meier method was used for the assessment of this outcome measure. |
Countries
Israel
Participant flow
Recruitment details
Retrospective data from Israel participants with hormone receptor positive (HR+)/ human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer and who initiated first or subsequent lines of palbociclib along with combination treatment (aromatase inhibitor \[AI\] or fulvestrant) and had at least 24 months of follow up post treatment initiation were planned to be observed.
Pre-assignment details
Data were identified and retrieved from Maccabi healthcare services (MHS) database for eligible participants who initiated palbociclib combination treatment from 01 January 2018 to 30 June 2020. The observation period was extended up to 30 June 2022 to include the follow up duration of minimum of 24 months post treatment initiation. Data was observed and evaluated during 18 months of this retrospective study (06 December 2020 to 30 June 2022) of this study.
Participants by arm
| Arm | Count |
|---|---|
| Palbociclib Participants with HR+/HER2- metastatic breast cancer, who had initiated palbociclib combination treatment in real world clinical practice as per the national basket of health services, were observed during this population based retrospective database study. | 559 |
| Total | 559 |
Baseline characteristics
| Characteristic | Palbociclib | — |
|---|---|---|
| Age, Continuous | 65.00 Years | — |
| Age, Customized <=65 Years | 278 Participants | — |
| Age, Customized >65 Years | 281 Participants | — |
| Body Mass Index (BMI) | 27.85 Kilogram per meter square | — |
| Number of Participants According to Deyo-Charlson Comorbidity Index Categories 0 | 241 Participants | — |
| Number of Participants According to Deyo-Charlson Comorbidity Index Categories 1-2 | 205 Participants | — |
| Number of Participants According to Deyo-Charlson Comorbidity Index Categories >=3 | 113 Participants | — |
| Number of Participants According to Histology of Breast Cancer Invasive ductal | 434 Participants | — |
| Number of Participants According to Histology of Breast Cancer Invasive lobular | 67 Participants | — |
| Number of Participants According to Histology of Breast Cancer Lobular and ductal | 19 Participants | — |
| Number of Participants According to Histology of Breast Cancer Other/missing/unknown | 39 Participants | — |
| Number of Participants According to Location of Metastases Bone | 394 Participants | — |
| Number of Participants According to Location of Metastases Brain | 15 Participants | — |
| Number of Participants According to Location of Metastases Lymph | 251 Participants | — |
| Number of Participants According to Location of Metastases Visceral | 261 Participants | — |
| Number of Participants According to Region of Residence Central | 379 Participants | — |
| Number of Participants According to Region of Residence North | 99 Participants | — |
| Number of Participants According to Region of Residence South | 81 Participants | — |
| Number of Participants According to Smoking History Current or former | 210 Participants | — |
| Number of Participants According to Smoking History Never | 349 Participants | — |
| Number of Participants According to Socioeconomic Status High | 239 Participants | — |
| Number of Participants According to Socioeconomic Status Low | 212 Participants | — |
| Number of Participants According to Socioeconomic Status Medium | 108 Participants | — |
| Number of Participants Categorized According to BMI Missing | 36 Participants | — |
| Number of Participants Categorized According to BMI Normal | 138 Participants | — |
| Number of Participants Categorized According to BMI Obese | 186 Participants | — |
| Number of Participants Categorized According to BMI Overweight | 190 Participants | — |
| Number of Participants Categorized According to BMI Underweight | 9 Participants | — |
| Number of Participants Categorized According to Hormone Receptor Sensitivity ER+ | 139 Participants | — |
| Number of Participants Categorized According to Hormone Receptor Sensitivity ER+/PR+ | 405 Participants | — |
| Number of Participants Categorized According to Hormone Receptor Sensitivity Missing | 11 Participants | — |
| Number of Participants Categorized According to Hormone Receptor Sensitivity PR+ | 4 Participants | — |
| Number of Participants who Used Other Medications Prior to Palbociclib Initiation | 0 Participants | — |
| Number of Participants who Visited Community/Hospital for Genetic Counselling | 170 Participants | — |
| Number of Participants With Chronic Disease - Depression | 174 Participants | — |
| Number of Participants With Co-morbidities Diagnosed in one Year Prior to Palbociclib Initiation Cardiovascular disease | 76 Participants | — |
| Number of Participants With Co-morbidities Diagnosed in one Year Prior to Palbociclib Initiation Chronic obstructive pulmonary disease (COPD) | 33 Participants | — |
| Number of Participants With Co-morbidities Diagnosed in one Year Prior to Palbociclib Initiation Diabetes mellitus | 133 Participants | — |
| Number of Participants With Co-morbidities Diagnosed in one Year Prior to Palbociclib Initiation Hypertension | 279 Participants | — |
| Number of Participants With Co-morbidities Diagnosed in one Year Prior to Palbociclib Initiation Ischemic heart disease | 27 Participants | — |
| Number of Participants With Co-morbidities Diagnosed in one Year Prior to Palbociclib Initiation Menopause | 439 Participants | — |
| Number of Participants With Co-morbidities Diagnosed in one Year Prior to Palbociclib Initiation Osteoporosis | 165 Participants | — |
| Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG: 0-1 | 311 Participants | — |
| Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG: 2-4 | 70 Participants | — |
| Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG: Missing | 178 Participants | — |
| Number of Participants With Germline Breast Cancer Gene Mutation (gBRCAm) Test Performed | 164 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 554 Participants | — |
| Sex: Female, Male Male | 5 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 269 / 559 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Duration of Index Treatment Per Type of Combination Treatment
Duration in months between the start and stop of therapy was reported. Index treatment was palbociclib combination treatment. Kaplan-Meier method was used for the assessment of this outcome measure.
Time frame: Day 1 of index treatment till discontinuation of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Population: Analysis population included all participants whose data were included and observed in the study. Here Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Palbociclib | Duration of Index Treatment Per Type of Combination Treatment | Palbociclib + AI | 30.5 Months |
| Palbociclib | Duration of Index Treatment Per Type of Combination Treatment | Palbociclib + Fulvestrant | 12.6 Months |
Primary
Number of Participants Categorized According to Initial Palbociclib Dose Per Type of Combination Treatment
Number of participants were categorized according to initial palbociclib dose. Index treatment was palbociclib combination treatment. Index period was defined as duration in which participant initiated palbociclib combination treatment.
Time frame: Day 1 of index treatment (any day from 01 January 2018 to 30 June 2020 [index period]), data observed and evaluated during 18 months of this retrospective study
Population: Analysis population included all participants whose data were included and observed in the study. Here Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Palbociclib | Number of Participants Categorized According to Initial Palbociclib Dose Per Type of Combination Treatment | Palbociclib + AI | 75 milligrams (mg) | 8 Participants |
| Palbociclib | Number of Participants Categorized According to Initial Palbociclib Dose Per Type of Combination Treatment | Palbociclib + AI | 100 mg | 23 Participants |
| Palbociclib | Number of Participants Categorized According to Initial Palbociclib Dose Per Type of Combination Treatment | Palbociclib + AI | 125 mg | 262 Participants |
| Palbociclib | Number of Participants Categorized According to Initial Palbociclib Dose Per Type of Combination Treatment | Palbociclib + Fulvestrant | 75 milligrams (mg) | 12 Participants |
| Palbociclib | Number of Participants Categorized According to Initial Palbociclib Dose Per Type of Combination Treatment | Palbociclib + Fulvestrant | 100 mg | 26 Participants |
| Palbociclib | Number of Participants Categorized According to Initial Palbociclib Dose Per Type of Combination Treatment | Palbociclib + Fulvestrant | 125 mg | 228 Participants |
Primary
Number of Participants Categorized According to Number of Cycles of Index Treatment Per Type of Combination Treatment
Number of participants categorized according to number of cycles of treatment including less than or equal to (\<=) 6, greater than (\>) 6 to 11, \>11 to 20 and \>20 cycles were reported. Index treatment was palbociclib combination treatment.
Time frame: Day 1 of index treatment till discontinuation of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Population: Analysis population included all participants whose data were included and observed in the study. Here Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Palbociclib | Number of Participants Categorized According to Number of Cycles of Index Treatment Per Type of Combination Treatment | Palbociclib + AI | <= 6 cycles | 44 Participants |
| Palbociclib | Number of Participants Categorized According to Number of Cycles of Index Treatment Per Type of Combination Treatment | Palbociclib + AI | >6 - 11 cycles | 37 Participants |
| Palbociclib | Number of Participants Categorized According to Number of Cycles of Index Treatment Per Type of Combination Treatment | Palbociclib + AI | >11 - 20 cycles | 66 Participants |
| Palbociclib | Number of Participants Categorized According to Number of Cycles of Index Treatment Per Type of Combination Treatment | Palbociclib + AI | >20 cycles | 146 Participants |
| Palbociclib | Number of Participants Categorized According to Number of Cycles of Index Treatment Per Type of Combination Treatment | Palbociclib + Fulvestrant | <= 6 cycles | 99 Participants |
| Palbociclib | Number of Participants Categorized According to Number of Cycles of Index Treatment Per Type of Combination Treatment | Palbociclib + Fulvestrant | >6 - 11 cycles | 47 Participants |
| Palbociclib | Number of Participants Categorized According to Number of Cycles of Index Treatment Per Type of Combination Treatment | Palbociclib + Fulvestrant | >11 - 20 cycles | 52 Participants |
| Palbociclib | Number of Participants Categorized According to Number of Cycles of Index Treatment Per Type of Combination Treatment | Palbociclib + Fulvestrant | >20 cycles | 68 Participants |
Primary
Number of Participants Categorized According to Type of Index Combination Treatment Regimen
Number of participants were classified on the basis of type of combination treatment along with palbociclib as first line therapy. Index treatment was palbociclib combination treatment. Index period was defined as duration in which participant initiated palbociclib combination treatment.
Time frame: Day 1 of index treatment (any day from 01 January 2018 to 30 June 2020 [index period]), data observed and evaluated during 18 months of this retrospective study
Population: Analysis population included all participants whose data were included and observed in the study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Palbociclib | Number of Participants Categorized According to Type of Index Combination Treatment Regimen | Palbociclib + Aromatase Inhibitor (AI) | 293 Participants |
| Palbociclib | Number of Participants Categorized According to Type of Index Combination Treatment Regimen | Palbociclib + Fulvestrant | 266 Participants |
Primary
Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 12 Per Type of Combination Treatment
Subsequent treatment after palbociclib therapy was the regimen received by participants following discontinuation from the palbociclib treatment. Number of participants who advanced and did not advance to a subsequent treatment up to Month 12 were reported. Index treatment is palbociclib combination treatment.
Time frame: Day 1 of index treatment up to Month 12 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Population: Analysis population included all participants whose data were included and observed in the study. Here Overall Number of Participants Analyzed signifies participants evaluable for the outcome measure. All participants reported under Overall Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Palbociclib | Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 12 Per Type of Combination Treatment | Palbociclib + AI | Advanced | 219 Participants |
| Palbociclib | Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 12 Per Type of Combination Treatment | Palbociclib + AI | Did not advance | 5 Participants |
| Palbociclib | Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 12 Per Type of Combination Treatment | Palbociclib + Fulvestrant | Advanced | 239 Participants |
| Palbociclib | Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 12 Per Type of Combination Treatment | Palbociclib + Fulvestrant | Did not advance | 3 Participants |
Primary
Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 24 Per Type of Combination Treatment
Subsequent treatment after palbociclib therapy was the regimen received by participants following discontinuation from the palbociclib treatment. Number of participants who advanced and did not advance to a subsequent treatment up to Month 24 were reported. Index treatment is palbociclib combination treatment.
Time frame: Day 1 of index treatment up to Month 24 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Population: Analysis population included all participants whose data were included and observed in the study. Here Overall Number of Participants Analyzed signifies participants evaluable for the outcome measure. All participants reported under Overall Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Palbociclib | Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 24 Per Type of Combination Treatment | Palbociclib + AI | Advanced | 223 Participants |
| Palbociclib | Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 24 Per Type of Combination Treatment | Palbociclib + AI | Did not advance | 1 Participants |
| Palbociclib | Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 24 Per Type of Combination Treatment | Palbociclib + Fulvestrant | Advanced | 242 Participants |
| Palbociclib | Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 24 Per Type of Combination Treatment | Palbociclib + Fulvestrant | Did not advance | 0 Participants |
Primary
Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 6 Per Type of Combination Treatment
Subsequent treatment after palbociclib therapy was the regimen received by participants following discontinuation from the palbociclib treatment. Number of participants who advanced and did not advance to a subsequent treatment up to Month 6 were reported. Index treatment is palbociclib combination treatment.
Time frame: Day 1 of index treatment up to Month 6 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Population: Analysis population included all participants whose data were included and observed in the study. Here Overall Number of Participants Analyzed signifies participants evaluable for the outcome measure. All participants reported under Overall Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Palbociclib | Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 6 Per Type of Combination Treatment | Palbociclib + AI | Advanced | 207 Participants |
| Palbociclib | Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 6 Per Type of Combination Treatment | Palbociclib + AI | Did not advance | 17 Participants |
| Palbociclib | Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 6 Per Type of Combination Treatment | Palbociclib + Fulvestrant | Advanced | 230 Participants |
| Palbociclib | Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 6 Per Type of Combination Treatment | Palbociclib + Fulvestrant | Did not advance | 12 Participants |
Primary
Number of Participants Who Died Following Initiation of Index Treatment up to Month 12 Per Type of Combination Treatment
Number of participants who died following index treatment up to Month 12 were reported. Index treatment was palbociclib combination treatment.
Time frame: Day 1 of index treatment up to Month 12 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Population: Analysis population included all participants whose data were included and observed in the study. Here Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Palbociclib | Number of Participants Who Died Following Initiation of Index Treatment up to Month 12 Per Type of Combination Treatment | Palbociclib + AI | 21 Participants |
| Palbociclib | Number of Participants Who Died Following Initiation of Index Treatment up to Month 12 Per Type of Combination Treatment | Palbociclib + Fulvestrant | 71 Participants |
Primary
Number of Participants Who Died Following Initiation of Index Treatment up to Month 24 Per Type of Combination Treatment
Number of participants who died following index treatment up to Month 24 were reported. Index treatment is palbociclib combination treatment.
Time frame: Day 1 of index treatment up to Month 24 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Population: Analysis population included all participants whose data were included and observed in the study. Here Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Palbociclib | Number of Participants Who Died Following Initiation of Index Treatment up to Month 24 Per Type of Combination Treatment | Palbociclib + AI | 58 Participants |
| Palbociclib | Number of Participants Who Died Following Initiation of Index Treatment up to Month 24 Per Type of Combination Treatment | Palbociclib + Fulvestrant | 119 Participants |
Primary
Number of Participants Who Died Following Initiation of Index Treatment up to Month 6 Per Type of Combination Treatment
Number of participants who died following index treatment up to Month 6 were reported. Index treatment was palbociclib combination treatment.
Time frame: Day 1 of index treatment up to Month 6 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Population: Analysis population included all participants whose data were included and observed in the study. Here Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Palbociclib | Number of Participants Who Died Following Initiation of Index Treatment up to Month 6 Per Type of Combination Treatment | Palbociclib + AI | 10 Participants |
| Palbociclib | Number of Participants Who Died Following Initiation of Index Treatment up to Month 6 Per Type of Combination Treatment | Palbociclib + Fulvestrant | 31 Participants |
Primary
Number of Participants With Modification (Reduction) in Initial Palbociclib Dose Per Type of Combination Treatment
Number of participants who had a reduction in initial palbociclib dose were reported. Index treatment was palbociclib combination treatment.
Time frame: Day 1 of index treatment till discontinuation of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Population: Analysis population included all participants whose data were included and observed in the study. Here Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Palbociclib | Number of Participants With Modification (Reduction) in Initial Palbociclib Dose Per Type of Combination Treatment | Palbociclib + AI | 96 Participants |
| Palbociclib | Number of Participants With Modification (Reduction) in Initial Palbociclib Dose Per Type of Combination Treatment | Palbociclib+ Fulvestrant | 82 Participants |
Primary
Percentage of Participants With Ongoing Index Treatment at Month 12 Per Type of Combination Treatment
Percentage of participants with ongoing index treatment at Month 12 were reported. Index treatment was palbociclib combination treatment.
Time frame: Day 1 of index treatment up to Month 12 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Population: Analysis population included all participants whose data were included and observed in the study. Here Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Palbociclib | Percentage of Participants With Ongoing Index Treatment at Month 12 Per Type of Combination Treatment | Palbociclib + AI | 76.3 Percentage of Participants |
| Palbociclib | Percentage of Participants With Ongoing Index Treatment at Month 12 Per Type of Combination Treatment | Palbociclib + Fulvestrant | 51.2 Percentage of Participants |
Primary
Percentage of Participants With Ongoing Index Treatment at Month 24 Per Type of Combination Treatment
Percentage of participants with ongoing index treatment at Month 24 were reported. Index treatment was palbociclib combination treatment.
Time frame: Day 1 of index treatment up to Month 24 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Population: Analysis population included all participants whose data were included and observed in the study. Here Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Palbociclib | Percentage of Participants With Ongoing Index Treatment at Month 24 Per Type of Combination Treatment | Palbociclib + AI | 54.7 Percentage of participants |
| Palbociclib | Percentage of Participants With Ongoing Index Treatment at Month 24 Per Type of Combination Treatment | Palbociclib + Fulvestrant | 26.0 Percentage of participants |
Primary
Percentage of Participants With Ongoing Index Treatment at Month 6 Per Type of Combination Treatment
Percentage of participants with ongoing index treatment at Month 6 were reported. Index treatment was palbociclib combination treatment.
Time frame: Day 1 of index treatment up to Month 6 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Population: Analysis population included all participants whose data were included and observed in the study. Here Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Palbociclib | Percentage of Participants With Ongoing Index Treatment at Month 6 Per Type of Combination Treatment | Palbociclib + AI | 91.0 Percentage of Participants |
| Palbociclib | Percentage of Participants With Ongoing Index Treatment at Month 6 Per Type of Combination Treatment | Palbociclib + Fulvestrant | 71.1 Percentage of Participants |
Primary
Time on Treatment for Subsequent Treatment After Palbociclib Therapy Per Type of Combination Treatment
Subsequent treatment after palbociclib therapy was the regimen received by participants following discontinuation from the palbociclib treatment and included chemotherapy, everolimus, fulvestrant and other. The duration between the start and stop of the post-palbociclib treatment was reported in this outcome measure. Index treatment was palbociclib combination treatment. Kaplan-Meier method was used for the assessment of this outcome measure.
Time frame: Day 1 of subsequent treatment till last dose of subsequent treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Population: Analysis population included all participants whose data were included and observed in the study. Here Overall Number of Participants Analyzed signifies the number of participants evaluable for this outcome measure. All participants reported under Overall Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Palbociclib | Time on Treatment for Subsequent Treatment After Palbociclib Therapy Per Type of Combination Treatment | Palbociclib + AI: Chemotherapy | 5.19 Months |
| Palbociclib | Time on Treatment for Subsequent Treatment After Palbociclib Therapy Per Type of Combination Treatment | Palbociclib + AI: Everolimus | 4.57 Months |
| Palbociclib | Time on Treatment for Subsequent Treatment After Palbociclib Therapy Per Type of Combination Treatment | Palbociclib + AI: Fulvestrant | 4.41 Months |
| Palbociclib | Time on Treatment for Subsequent Treatment After Palbociclib Therapy Per Type of Combination Treatment | Palbociclib + AI: Other | 12.89 Months |
| Palbociclib | Time on Treatment for Subsequent Treatment After Palbociclib Therapy Per Type of Combination Treatment | Palbociclib + Fulvestrant: Chemotherapy | 6.08 Months |
| Palbociclib | Time on Treatment for Subsequent Treatment After Palbociclib Therapy Per Type of Combination Treatment | Palbociclib + Fulvestrant: Everolimus | 4.44 Months |
| Palbociclib | Time on Treatment for Subsequent Treatment After Palbociclib Therapy Per Type of Combination Treatment | Palbociclib + Fulvestrant: Fulvestrant | 7.76 Months |
| Palbociclib | Time on Treatment for Subsequent Treatment After Palbociclib Therapy Per Type of Combination Treatment | Palbociclib + Fulvestrant: other | 4.37 Months |
Primary
Time to Initiation of Chemotherapy After Cessation of Initial Palbociclib Therapy Per Type of Combination Treatment
Time to initiation of chemotherapy was the duration from end of index treatment up to start of chemotherapy. Index treatment is palbociclib combination treatment.
Time frame: From cessation of index treatment up to initiation of chemotherapy (during 01 January 2018 to 31 December 2020 [approximately 36 months]); data observed and evaluated during 18 months of this retrospective study
Population: Analysis population included all participants whose data were included and observed in the study. Here Overall Number of Participants Analyzed signifies the number of participants evaluable for this outcome measure. All participants reported under Overall Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Palbociclib | Time to Initiation of Chemotherapy After Cessation of Initial Palbociclib Therapy Per Type of Combination Treatment | Palbociclib + AI | 0.79 Months |
| Palbociclib | Time to Initiation of Chemotherapy After Cessation of Initial Palbociclib Therapy Per Type of Combination Treatment | Palbociclib + Fulvestrant | 0.92 Months |
Primary
Time to Initiation of Next Treatment (TTNT) From Initiation of Palbociclib Treatment Per Type of Combination Treatment
TTNT was defined as the interval between the start of the index treatment date and the date of the next-line treatment. Participants who did not advance to the next treatment were censored on the study end date or death, whichever occurred first. Index treatment is palbociclib combination treatment. Kaplan-Meier method was used for the assessment of this outcome measure.
Time frame: Day 1 of index treatment up to initiation of next treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study
Population: Analysis population included all participants whose data were included and observed in the study. Here Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Palbociclib | Time to Initiation of Next Treatment (TTNT) From Initiation of Palbociclib Treatment Per Type of Combination Treatment | Palbociclib + AI | 34.5 Months |
| Palbociclib | Time to Initiation of Next Treatment (TTNT) From Initiation of Palbociclib Treatment Per Type of Combination Treatment | Palbociclib + Fulvestrant | 16.4 Months |